MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-05-30 for GORE VIATORR TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION PTB8108275 manufactured by W.l. Gore & Associates.
[146524045]
The gore? Viatorr? Tips endoprosthesis delivery catheter and deployment line were returned for analysis (stent remains implanted). The catheter was inspected and there was no zipper attached at the proximal bump. No other anomalies were observed on the catheter. The deployment line was inspected and found to be broken. The break appeared to be indicative of a tensile break. The returned deployment line only measured 86 cm, indicating that a part of the deployment line remained with the device or was not returned. The engineering evaluation could not determine why the deployment line became stuck and eventually broke, or why there were two sections of the stent that were not fully open. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[146524046]
It was reported the physician selected a gore? Viatorr? Tips endoprosthesis for a transjugular intrahepatic portosystemic shunt procedure. The device was placed and the bare metal portion was deployed without issue. After deploying approximately one third of covered portion of the stent, the deployment line became stuck. Several maneuvers were attempted to fully deploy the stent; however, the deployment line eventually broke. The delivery system was removed and a balloon was advanced into the stent to attempt and release the remaining constrained portion. Following this process, there were two sections of stent that were not fully open. The procedure was concluded and there were no reported adverse effects to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007284313-2019-00160 |
| MDR Report Key | 8654241 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-05-30 |
| Date of Report | 2019-06-17 |
| Date of Event | 2019-05-01 |
| Device Manufacturer Date | 2019-03-09 |
| Date Added to Maude | 2019-05-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MARCI STEWART |
| Manufacturer Street | 1500 N. 4TH STREET |
| Manufacturer City | FLAGSTAFF AZ |
| Manufacturer Phone | 9285263030 |
| Manufacturer G1 | MEDICAL PHOENIX 1 B/P |
| Manufacturer Street | 32360 N. NORTH VALLEY PARKWAY |
| Manufacturer City | PHOENIX AZ 85085 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 85085 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GORE VIATORR TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION |
| Generic Name | SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS |
| Product Code | MIR |
| Date Received | 2019-05-30 |
| Returned To Mfg | 2019-05-08 |
| Catalog Number | PTB8108275 |
| Lot Number | 20331020 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | W.L. GORE & ASSOCIATES |
| Manufacturer Address | FLAGSTAFF AZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-30 |